Sunshine and Aggregate Spend Sunshine and Aggregate Spend - CBI

Sunshine and Aggregate Spend Sunshine and Aggregate Spend - CBI


r e g i s t e r a t w w w . c b i n e t . c o m / a g g s p e n d


6 th Annual


The Longest Running and Best-Attended Meeting on


Credits Available!

Pending Approval

Sunshine and Aggregate Spend

Stay Ahead of the Curve to Ensure Transparency Readiness

June 2012

Deadline Set by

Senators Grassley and Kohl

for Final Regulations to Be Issued

August 2012


Ensure Enterprise


January 2013

CMS Requires Data

Collection to Begin

A u g u s t 14 -1 6 , 2 0 1 2 • R e n a i s s a n c e D o w n t o w n • W a s h i n g t o n , D C

W hy Mo re t h a n 350 Execu t ive s R e ly o n T h i s P rog ra m :

Critical Government Updates on Transparency and

Disclosure Regulations

Including: CMS, Senate Special Committee on Aging

and Vermont AG’s Office

Opportunity to Participate in the Annual Industry

Benchmarking Exercise

Led by: Pfizer Inc and Abbott

CCO Address — Strategy Initiatives Around Spend Data

Presented by: Wright Medical Technologies

Industry Peers Sharing Real-World Case Studies and Experiences

Including: Bayer, Dendreon, EMD Serono, Eisai, Eli Lilly, GSK, Mylan, Novartis, Otsuka,

Sunovion, Shire, Takeda and More!

Pre-Conference Workshops for All Levels of Expertise

A: The Fundamentals of Sunshine Compliance and Aggregate Spend Solutions

B: Aggregate Spend Systems, Processes and Data — A Deep Dive

Plus! New to the Conversation this Year...

Association of Clinical Research Organizations (ACRO), Quintiles, PPD and Others!

2012 Silver Sponsor

C o m p l i a n c e C o n s u l t i n g L e a d e r s C i r c l e

2012 Affiliate Sponsors

Educational Sponsor:

Media Partners:



Day One – Tuesday, August 14, 2012 • Choose Between Two Concurrent Pre-Conference Workshops



W o r k s h o p A

The Fundamentals of Sunshine Compliance and Aggregate Spend Solutions

12:30 Workshop Registration

1:30 Workshop Leaders’ Welcome and Opening Remarks

Workshop Objective:

For those new to the aggregate spend team or compliance function, or for those

who need a refresher, this “back to basics” course explores both the state and

federal laws and requirements related to HCP spend transparency and foundational

knowledge around the key components of an aggregate spend solution.

Key Questions to Be Addressed:

• What are the requirements outlined in the Physician Payments

Sunshine Act and how did we get to the federal regulations we’re at today?

• What states have similar transparency and reporting requirements?

• What parts of my organization are involved in Sunshine compliance

and reporting?

• What are the basic components to an aggregate spend solution?

Workshop Outline:

I. Explore the State and Federal Transparency and Disclosure Laws

Related to HCP Spend Collection and Reporting

• Analyze the federal Sunshine provisions passed in Section 6002


• Discuss the key requirements proposed by CMS in its draft regulations

• Learn the state requirements related to HCP spend transparency and

disclosure — Which states require reporting, what they require and

when reports are due


Identify and Manage Players Involved in Transparency and

Aggregate Spend Initiatives

• Discover which internal business units need to be involved

• Explore which external partners have spend data that must be reported

• Enact training and communication programs that ensure awareness and

outline responsibilities


Understand the Pieces of an Aggregate Spend System and Solution

• Discuss the importance of the customer master

• Identify all spend touch points across the organization

• Determine core business processes that must be implemented for

timely and accurate data capture

• Understand how technology solutions can help automate processes

• Evaluate necessary resource allocation of funds and personnel to

meet requirements

There will be a 30-minute networking and refreshment break at 3:00 p.m.

5:00 Close of Workshop A • Close of Day One

Workshop Leaders:

Jack Tanselle is a Managing Director at Navigant Consulting, Inc. with more than fourteen years

of life sciences experience in industry management roles and consulting. In the process of assisting clients

with compliance effectiveness assessments, program development and implementation and compliance

auditing and monitoring, Mr. Tanselle also assists clients with consulting and technology services support

related to aggregate spend reporting of HCP relationships at the state and federal level. He also assists

clients working through the requirements associated with government settlements, as part of IROs,

Pre-IROs and on teams serving as advisor to the Board of Directors and commercial business leaders.

Laura Sciarrino is a Director at Navigant Consulting, Inc., specializing in assisting pharmaceutical,

biotechnology and medical device manufacturers with regulatory compliance issues. A licensed attorney

for twenty years with more than twelve years of in-house legal and compliance experience, including

positions as Chief Legal Officer and Compliance Officer, Ms. Sciarrino has extensive experience with

compliance related to federal and state reporting requirements, as well as risk assessment and mitigation,

compliance program development, internal and external investigations and litigation.

Matt Kunkel is an Associate Director at Navigant Consulting, Inc. with more than eight years

of experience in connection with technology-based solutions for fraud investigations, compliance,

forensic accounting, business intelligence and FCPA issues. Mr. Kunkel is currently leading Navigant’s

Technology Services group with respect to the development of various customized aggregate spend

solutions for life sciences companies.

5:00 – 6:00 Networking, Wine and Cheese Reception

T o R e g i s t e r C a l l T o l l F r e e 8 0 0 - 8 1 7 - 8 6 0 1 ( 3 3 9 - 2 9 8 - 2 1 0 0


Day One – Tuesday, August 14, 2012 • Choose Between Two Concurrent Pre-Conference Workshops



W o r k s h o p B

Aggregate Spend Systems, Processes and Data — A Deep Dive

12:30 Workshop Registration

1:30 Workshop Leaders’ Welcome and Opening Remarks

Workshop Objective:

With the implementation of the Sunshine Act quickly approaching, most life

sciences organizations have addressed the fundamental challenges of identifying,

capturing, and reporting spend activities. For the purposes of this workshop,

we would like to take a step back and discuss ways in which organizations can

leverage these new systems, processes, and data to support aggregate spend

compliance and other requirements. The specific topics to be addressed include

opportunities to introduce Business Process Innovation to meet additional

business needs and testing data sets for potential compliance risks.

Key Questions to Be Addressed:

• What additional value can be extracted from the actual processes developed for

aggregate spend compliance?

• How can the information from the processes be leveraged for improvements in

other areas of the business?

• What procedures can be developed to determine whether aggregate spend

systems and people are performing as expected?

• How could potential compliance risks be identified prior to Sunshine reporting?

Workshop Outline:

I. Conduct Upstream Data Analytics

• Develop procedures to reconcile report data to source systems and

identify potential risks or gaps


Introduce Business Process Innovation

• Identify opportunities to re-use aggregate spend process components for

better business optimization and compliance results

There will be a 30-minute networking and refreshment break at 3:00 p.m.

5:00 Close of Workshop B • Close of Day One

Workshop Leaders:

Rick Zimmerer is a Partner at KPMG. He has more than twenty years experience assisting life

sciences organizations with a wide variety of compliance and litigation matters in areas such as

aggregate spend, government pricing, payer litigation (AWP, Off-Label and/or Product Liability) and

government contracts/grants. He has testified as an expert in these matters on multiple occasions.

Rajesh Misra is a Director at KPMG. He has more than twenty years experience in developing

technology-based solutions for leading global organizations in the pharmaceutical industry.

He has assisted several leading pharmaceutical organizations in architecting, designing and

implementing a Business Process Management enabled aggregate spend solution. He also helps

clients take advantage of emerging technology to develop cost-effective compliance solutions.

Andy Parks is a Director in KPMG’s Washington, DC office. He has assisted a variety of

organizations with aggregate spend matters such as solution design and data-driven compliance

assessments. Mr. Parks’s life sciences industry experience also includes various disputes,

investigations and pharmaceutical government pricing assistance.

Katie LaBauve is a Manager in KPMG’s Life Sciences Practice. She specializes in providing

aggregate spend compliance assessments and process re-engineering services to pharmaceutical,

biotechnology and medical device manufacturers.


Conduct Downstream Data Analytics

• Develop procedures to assess report output for potential risks related to

compliance, disputes, third-party perception and other matters

William Lit is a Manager in KPMG’s San Francisco Office. He has focused on advanced data

analytics for compliance, investigative and litigation matters. He has performed detailed data analytics

with aggregate spend data and led teams computing a variety of government pricing calculations.

5:00 – 6:00 Networking, Wine and Cheese Reception

o u t s i d e t h e U . S . ) o r v i s i t w w w . c b i n e t . c o m / a g g s p e n d

Main Conference • Day Two — Wednesday, August 15, 2012

7:00 Main Conference Registration and Continental Breakfast

8:00 Chairman’s Welcome and Opening Remarks

Ashish Kalgaonkar,

Senior Director, Global HCP Transparency Reporting,

Eli Lilly & Co.

C M S U p d a t e

8:15 Q&A with CMS on the Implementation of Sunshine Regulations

Since February, when the comment period on the draft regulations

closed, CMS has been working towards developing final regulations

for the industry. Attendees have the opportunity to submit questions in

advance of the meeting for a representative from CMS.

Niall Brennan, Acting Director, Policy and Data Analysis Group, CMS

C o n g r e s s i o n a l U p d a t e

8:45 Congressional Perspective on the Progress of the Implementation

of Sunshine

The Committee on Aging, chaired by Sen. Herb Kohl, postponed

a planned oversight hearing in December when CMS issued its draft

regulations. In April, Sens. Chuck Grassley and Kohl sent a letter to

CMS urging final regulations to be issued by June. In this session, hear

an update from Congress on its view of the progress being made on the

implementation of Sunshine and learn next steps it plans to take.

Sarah Levin, Senior Health Policy Advisor, Special Committee on Aging, U.S. Senate

9:15 Update from the National Trade Associations on

Regulations Development

A number of trade associations submitted comments to CMS regarding its

proposed rule on behalf of their member companies, including all of the

major life sciences trade associations. Examples of some common topics

included requests that the Agency provide more clarity around various

definitions and concerns regarding potential mischaracterizations if the

information is not put in appropriate context. In this panel discussion, hear

about the continuing efforts and dialogue the trade associations engage in

with the government as the industry moves towards implementation.

Moderator: Judy Fox, Director, Commercial Compliance, CIS

(Compliance Implementation Services)

Panelists: Kendra A. Martello, Assistant General Counsel, PhRMA






(Pharmaceutical Research and Manufacturers of America)

Sandra J.P. Dennis, Deputy General Counsel for Healthcare, BIO

(Biotechnology Industry Organization)

Thomas C. Novelli, Vice President, Government Affairs, MDMA

(Medical Device Manufacturers Association)

Doug Peddicord, Ph.D., Executive Director, ACRO

(Association of Clinical Research Organizations)



10:00 Networking and Refreshment Break hosted by:

10:30 The Physician Role in Manufacturers’

Sunshine and Transparency Initiatives

A coordinated effort to ensure data accuracy should exist between

manufacturers and the physicians for whom they’re reporting spend data.

Manufacturers are currently developing processes to communicate spend

data prior to reporting and mechanisms for physicians to dispute claims. But,

what do physicians think? From December 2011–January 2012, a joint survey

was conducted with the American Medical Association (AMA) to better

understand aggregate spend awareness and attitudes amongst physicians,

including specific feedback on how best HCPs would like to review,

benchmark and dispute spend data. Hear the results of the survey for insight

as to how best approach HCP communications in your agg spend solution.

Tim Robinson, Esq., President, Regulatory Law Group, PLLC; General Counsel, MMIS, Inc.

S t a t e U p d a t e

11:00 Vermont’s Regulation, Uses of Reported Data and Insight on Preemption

While the details surrounding federal disclosure requirements remain

unclear, state laws have regulated the industry by requiring disclosures

related to HCP transparency for years. This includes Vermont’s Prescribed

Product Gift Ban and Disclosure Law which requires manufacturers to file

a report with the Attorney General’s Office each April. In this state session,

get updates on guidance surrounding Vermont requirements, learn about

the uses to which the state puts the data, and gain insight into the impact

federal Sunshine requirements may have on regulating states.

• Hear about updates made to the 2012 Guide to Vermont’s Gift Ban

and Disclosure Law related to expenditures and samples.

• Explore what states learn from manufacturer reports and what

they may do with the information from an enforcement perspective

• Hear a state perspective on preemption as it relates to federal

Sunshine requirements

Kate Whelley McCabe, Assistant Attorney General, Public Protection Division,

Vermont Office of the Attorney General

11:30 Unpacking the FDA Federal Prescription Drug Sample

Transparency Regulations

In April, the FDA released proposed regulations regarding the Federal

Prescription Drug Sample Transparency provisions of Section 6004 of the

Affordable Care Act. This discussion breaks down what is being required by the

FDA for industry to report regarding sample transparency on October 1, 2012.

• Compare the differences between PDMA requirements and new sample

transparency requirements

• Understand the scope of reporting requirements, including whether these

provisions extend to coupons and vouchers

John P. Oroho, Principal, Porzio, Bromberg & Newman, P.C.

12:00 Luncheon



1:15 Managing Aggregate Spend Requirements Across

Multiple Companies — From Parents to Subsidiaries

Companies should have a plan in place to address the

requirements, as outlined in the proposed CMS regulations,



for reporting spending activities as they pertain to parent companies and

their diverse business units. In this session, explore common questions

regarding reporting across affiliates and learn how some companies are

currently handling these circumstances.

• Address common questions raised by this provision

* who is required to report?

* are reports filed separately for different groups and organizations?

• Explore potential reporting requirements based on the legislation

• Hear real-world examples of how reporting is handled at

companies based in the U.S. but operated or acquired by

international companies, often with multiple subsidiaries

Jonathan Wozniak, Project Manager, QPharma, Inc.

1:45 Keeping Up With Transparency Legislation Trends and

Requirements Outside the U.S.

While the industry gears up for Sunshine implementation in

the U.S., new codes, regulations and guidelines with similar HCP spend

transparency requirements are emerging throughout Europe and other

parts of the world. Gain a basic understanding of current and pending

provisions in different regions, as well as considerations for how these

laws and regulations may impact Sunshine and state spend collection

and reporting efforts in the U.S.

• Understand HCP spend transparency requirements set forth in France,

The Netherlands, Slovakia, Japan, Australia and other countries

• Analyze the impact of current country requirements in relation

to the development of new regulations in other areas

• Explore the new International Federation of Pharmaceutical

Manufacturers and Associations (IFPMA) Code of Practice

Seth H. Lundy, Partner, King & Spalding, LLP

2:15 Global Transparency — Approaches and Considerations

Organizations are turning their attention to the convergence of

international transparency regulations and industry codes

governing how they interact with their customers. In this session,

we discuss the approaches to understanding the requirements and

how organizations are responding to address these international

requirements. This session includes approaches and considerations

from mobilizing the initiative to map out the solution, to the

organizational structure that will be required to support the solution

in an on-going basis. Discussion topics include:

• What are the challenges organizations are facing?

• What are the considerations or options organizations have to consider?

• Is there a one-size-fits-all approach?

• What do the needs for a Governance Support Structure look like?

Mike McNeal, Manager, PwC

Sarah Volden, Manager, PwC

2:45 Networking and Refreshment Break

C C O A d d r e s s

3:15 Developing Strategy Initiatives around Aggregate Spend Data

While transparency and aggregate spend teams are busy revising

policies and refining data collection and reporting processes to ensure

operational readiness for federal reporting, those in Senior Management

positions across the industry are considering the strategic impact these

regulations will have on their organizations. In this Address, explore the

strategic initiatives one CCO considers as the industry moves closer to

implementation of Sunshine.

• Increase organizational efficiencies by streamlining the compliance

department’s role in the operation of Sunshine initiatives

• Leverage spend data for business intelligence mining

• Build a communication strategy around reporting information

Daniel J. Garen, Senior Vice President and Chief Compliance Officer,

Wright Medical Technology, Inc.

3:45 Aggregate Spend Next Steps

While ensuring readiness for reporting is top of mind for most companies,

this session explores what next steps aggregate spend and transparency

teams should be considering.

• Performing data-driven compliance assessments

• Conducting report output analytics

• Deriving value from other organizations’ data

• Scaling the process across other elements of the business

Andy Parks, Director, KPMG

Rajesh Misra, Director, KPMG

4:30 Industry Benchmarking Exercise

Each year at this meeting, attendees use a live polling system to

benchmark their interpretations of the regulations and their progress on

the implementation of their aggregate spend solutions. Results of the

benchmarking exercise are shared after the conference for companies

to use as another tool while finalizing their transparency and aggregate

spend policies, processes, resource allocations and systems.

Roma Tretiak, Senior Director/Group Leader, Transparency, Pfizer Inc

Melissa Ince, Director, Transparency Reporting, Office of Ethics and Compliance, Abbott

5:45 Close of Day Two

5:45 – 6:45 Networking, Cocktail Reception hosted by:

Day Three — Thursday, August 16, 2012

7:30 Continental Breakfast 8:00 Tracked Programming Begins



T r a c k A : C u s t o m e r M a s t e r , D a t a C o l l e c t i o n a n d M a n a g e m e n t C o n s i

T r a c k B T r a c k A




and Opening


Theresa Greco,

Senior Vice

President of


Operations and

Client Solutions,

Health Market





and Opening


Rick Zimmerer,



8 : 0 0 – 1 : 1 5 • T r a c k e d P r o g r a m m i n g —

8:00 8:15 9:00



Develop a Customer Master Index

The core piece to any aggregate spend

solution is the development of a unique identifier for each

HCP associated with reportable spend. Hear how one

company approached this daunting task by finding and

matching HCPs using already determined individual identifiers

to develop a customer master index of NPIs, state license(s),

company customer IDs and DEA numbers.

• Analyze NPI taxonomy versus drug label indications to

evaluate HCP’s eligibility for marketing/attendee

targeting efforts

• Learn methods for resolving HCPs with common names

• Explore methods to resolve/identify HCPs with

uncommon names

• Hear how to validate the “matching results”

Joe Wholley, Executive Director, Internal Audit and Compliance,


Establish Accountability and Process

Design to Support Data Completeness

Typically, the owners of the aggregate spend solution are not the

ones who collect and enter data into a source system. As a result,

processes and associated accountability should be in place to ensure

that the individuals who originate value exchanges with HCPs and

HCEs – whether internal or external – have a clear understanding of

accountability and available tools to provide complete spend data.

• Learn about the process for reviewing dashboard reports to

identify potential inaccurate or incomplete data

• Employ processes to support adjustments to previously

submitted data — Meal expenses, advisory board honorariums,

educational grants, etc.

• Discover how front end loading responsibilities and process

discipline provide the capability increase data completeness

Dobson Schofield, Compliance Operations Director, Office of Ethics and Compliance,

Takeda Pharmaceuticals U.S.A., Inc.

Resolve Conflicts in MDM —

How to Be Proactive versus Reactive

While some pharmaceutical and medical device manufacturers scramble to

stand-up data collection and reporting systems, others are taking this short-lived

opportunity to examine their data management approach for healthcare recipient

and expense information. Prudent adjustments now can have a profoundly

positive impact on recipient and expense integration and aggregation systems

and processes. Bottom line, the more rigor you impose upfront in discovering,

define, and validating aggregate spend data element requirements, the fewer

costly changes you face down the road. Experience shows proactively integrating

data into upstream source systems can reduce time-consuming data remediation

activities downstream. Yet, changing the company culture to be more proactive

in properly documenting spend data may be your biggest challenge.

• Discuss pragmatic options that impact business as usual

• Align technology with organizational behavior

• Explore ways to improve compliance and reduce risk of exposure

• Meet transparency requirements without draining precious resources

Greg Maynard, Solution Director, Life Sciences Compliance, Health Market Science

Darryl Williams, Solution Director, Professional Services, Health Market Science

T r a c k B : B u s i n e s s P r o c e s s I m p r o v e m e n t s a n d S p e n d D a t a A n a l y t i c s

8:00 8:15 9:00



Manage HCP Interactions within the Contracting Continuum

Manufacturers are now looking to streamline business processes and

systems related to the front end of the spend reporting process at time

of data collection. Specifically, this session tackles challenges and

highlights solutions that the industry faces with respect to managing

consulting agreements with HCPs as related to the following areas:

• HCP qualification

• Contract authoring

• Contract negotiations process

• Engagement

• Service delivery

• Payment process

Spend reporting

Moderators: Becky Holloway, Product Marketing Manager, Life Sciences Compliance, Revitas

Mark Linver, Managing Director, Huron Life Sciences

Panelists: Michelle Scharfenberg, Senior Corporate Counsel, Integra Life Sciences

Brian Welch, Deputy Compliance Officer, Mylan Inc.

Melissa F. LaFrain, Senior Manager, Operational Review, Corporate Compliance,

Wright Medical Technology, Inc.

Suj Patel, Director, Huron Life Sciences






C h o o s e B e t w e e n T w o C o n c u r r e n t T r a c k s

d e r a t i o n s



10:30 11:00



Clinical Transparency — Data Capture,

Process Improvement and Change Management

Understand the implementation process of a clinical transparency program developed at

one company to meet the requirements of Sunshine legislation. Explore how companies

have defined program scope, identified and executed process and system changes and

obtained buy-in from key personnel through a change management program.

• Identify customer and expense data that is relevant to the program

• Work across the organization to establish clinical transparency business

requirements that are inclusive of different geographies, therapeutic

areas and business units

• Determine whether your organization has the internal technical

resources to complete necessary system modifications or whether an

external vendor must be engaged to execute system modifications

• Deploy a change management program for

clinical employees impacted by process and system change

Moderator: Marci Juneau, Manager, Huron Life Sciences

Panelists: Joseph Morrell, Manager, Huron Life Sciences

Sharon L. Muscato, Senior Manager, Compliance Data Management Team, EMD Serono, Inc.

Nina Lepski, Head Operations, Novartis Pharmaceuticals Corporation

Luanna Saulino, Associate Director, Disclosure Law and Transparency Operations, Bayer HealthCare

Jen Seligman, Manager, Disclosure Law and Transparency Operations, Bayer HealthCare












Lessons Learned in Developing a Vendor Management

Program — The Journey to Improving Data Quality

All disclosure and transparency teams are charged with

ensuring that their organization is disclosing complete and

accurate information related to all reportable HCP/HCO activity…

even those being managed by external vendors. The task is a lofty

one. The amount of reportable spend that is collected through your

company’s vendor partners, who are performing work on your behalf,

can be quite significant – if not in volume, then in complexity.

Because of the limited amount of control a company has on internal

vendor business practices, vendors requiring disclosure may pose the

greatest risk to your company’s disclosure objectives. This session

explores a manufacturer’s journey in evaluating the quality of their

vendor data, identifying root causes of error and re-engineering their

vendor management approach to proactively improve data quality

and reduce unnecessary corrective efforts.

Wanda Toro Turini, Pharm.D., President and Lead Advisor,

Bull’s Eye Innovations Corp.

9:45 10:30 11:00

Aggregate Spend Solution Auditing and Monitoring

Companies today have put forth considerable efforts in terms of time,

resources and financial investment to implement their aggregate spend

and transparency environments. Now these same organizations are

wanting to know if they have thought through this correctly, and

whether their environment is satisfying their initial requirements.

This session explores the multitude of questions organizations are

trying to answer, in terms of:

• Are they capturing their spend correctly? At the appropriate level?

• Have they increased their oversight and improved compliance around

these activities?

• Is the technology really enabling their processes?

• Is their solution scalable to meet additional needs of the organization?

• Where are the efficiencies gained and what is the return on

their investment?

Jonathon L. Kellerman, Partner, Pharmaceutical and Life Sciences Practice, PwC





Turning Your Agg Spend Data into Sunshine Information

While there is still not clarity as to exactly when the first federal

Sunshine report will be due to CMS, many believe that the

government will want first reports not long after the final

regulations are issued. This means that companies should be

thinking about how they would compile those reports now.

In this panel, explore considerations to take into account to

ensure smooth execution of reporting, including:

• Resolving conflicts in your customer master

• Approaches for meal allocations

• Interpretations of transfer of value

• Scoping nature of payments

Moderator: John Nause, Senior Manager, Government Contracts and Pricing,

Dr. Reddy’s Laboratories, Inc.


Timothy S. Ayers, Vice President, Chief Compliance Officer, Dendreon Corporation

Jennifer McGee, Senior Compliance Counsel, Otsuka America Pharmaceutical, Inc.






8 : 0 0 – 1:15 • Tr a c k e d P r o g r a m m i n g (C o n t i n u e d) — C h o o s e B e t w e e n Tw o C o n c u r r e n t Tr a c k s

T r a c k A : C u s t o m e r M a s t e r , D a t a C o l l e c t i o n a n d M a n a g e m e n t C o n s i d e r a t i o n s

Track A (continued)

11:45 12:30

Improve Data Collection Involving Third-Parties that

Make Payments on behalf of Manufacturers

There remain a number of complexities related to the management of

the collection of data for direct and indirect payments to HCPs.

In this panel, hear both the manufacturer and third-party perspectives

on the challenges of gathering this data and solutions being developed

to streamline the process.

• Discuss the risks associated with data reporting for each side

(manufacturers and third-party) under Sunshine

• Explore challenges related to accuracy, completeness and timeliness of the reporting

• Define roles and responsibilities in the reporting process

• Examine intricacies related to the timing difference between when

manufacturers pay the third-party and when the third-party pays the HCP

(pre-payments, advances, reconciliations)

Moderator: D. Jeffrey Campbell, Principal, Porzio, Bromberg & Newman, P.C.

Panelists: Patti McNamara, Vice President, Finance, PPD

Kim Zahan, Director, R&D and HCP Compliance, GlaxoSmithKline

Vanessa Yeung, Manager, Transparency Compliance Reporting, BD

Toby Ann Holetz, Senior Clinical Project Manager, Therapeutic Delivery Solutions, Quintiles

Teresa Hall, CEO, Meetings and Events International

Identify and Use HCP Affiliations for Compliance,

Sales Force Optimization and Analytics

Companies are gathering a vast amount of data about their HCP and HCO customers

to comply with state and Sunshine regulations, as well as prepare themselves for

potential future reporting obligations. However, to make this data even more

valuable to the organization, companies must also understand the relationships

between HCPs and HCOs. In this session, explore ways to define, identify and

leverage information about HCP/HCO accounts and affiliations, including how to:

• Identify all HCPs within a group or organization

• Classify all HCOs by location

• Link providers across common specialties within organizations and locations

• Determine the best contact information

• Link providers via persistent identifiers

• Enable ongoing data accuracy validation including account “inclusion”

and “exclusion” functionality

• Expand HCP/HCO profiles to include multi-location relationships,

additional phone/fax instances, recency metrics, etc.

Warren Gouk, Chief Financial Officer, Head of Business Development, Enclarity, Inc.

Stephanie Rose-Belcher, Vice President, Product Strategy and Compliance, Enclarity, Inc.

Implement a Standardized Strategy for Sunshine

and FMV Compliance for Investigator Grant Spend

Learn about the approach taken by one company to contend with

the challenges of Sunshine and FMV compliance, while balancing

the needs of clinical operations and the critical investigator

relationship. This session showcases a real-world implementation

and highlights best practices to satisfy all key stakeholders.

• Streamline the feed of clinical payment data into enterprise

aggregate spend solutions

• Improve investigator relationships

• Implement an FMV strategy — Establish internal controls,

budget review processes and more

• Centralize investigator grant spend while still leveraging

multiple CROs

Jim DiCesare, Vice President and General Manager, Contract and Regulatory Services,

CFS Clinical

Brenda Medina, Head of Clinical Business Operations, Eisai

T r a c k B : B u s i n e s s P r o c e s s I m p r o v e m e n t s a n d S p e n d D a t a A n a l y t i c s

Track B (continued)

11:45 12:30






Learn How Aggregate Spend and Disclosure

Can Feed a “Big Data” Initiative in Life Sciences





While the buzzword “Big Data” is all the rage across all industries,

Life Sciences has been slow to embrace how this new paradigm can

optimize Commercial Operations. Due to the requirements of an

aggregate spend initiative, multiple data sources are now stored in

one area to finally create a true single view of the customer. In this

session, review a real-world example of an organization pushing

forward with data in a unique way to include:

• Understanding all the various data sets across an organization and

what they entail

• Creating a cloud-based model to house data and perform analytical

models to become more predictive

• Managing various visualization techniques to create dashboards for

different units, e.g. Compliance, Commercial Operations, Finance, etc.

Moderator: Revi Pearl, Associate, Huron Life Sciences


Manny Tzavlakis, Managing Director, Huron Life Sciences

John Poulin, Director, Huron Life Sciences

Sam Chud, Senior Director, Business Operations and Sales Effectiveness (BOSE), Shire

1:15 • Close of Track A / Luncheon

1:15 • Close of Track B / Luncheon



1:15-2:15 Luncheon • 2:15-4:00 Working Group Discussions — Choose Between Six Topics

Identify Solutions to Common Challenges and Develop Best Practices

Engage in conversations with your peers during the Working Group Discussions. A facilitator leads the group by sharing first-hand experiences and

asking specific questions to help spark discussion around the practical issues surrounding the topic. Choose one of the six topics offered:

#1 Understanding and Maintaining Customer and Vendor Masters

• Explore common customer and vendor data management challenges

• Discuss changes to the contracting process to improve data capture

• Share approaches to managing customer relationships and vendor hierarchies


Chris Colapietro, Senior Vice President Life Sciences, HighPoint Solutions

John Wollman, Executive Vice President, HighPoint Solutions

#4 Uses for Data beyond Reporting — Compliance Monitoring,

Key Performance Indicators and Business Analytics

• Leverage spend data to detect potential fraud and abuse issues

• Build KPIs (Key Performance Indicators) into your continuous monitoring program

• How to get additional value out of your data


Bharathram Lakshmivarahan, Manager, Pharmaceutical and Life Sciences Practice, PwC

Wendy Tsuei, Associate Director, State and Federal Reporting, Eisai

#2 Roadmap to Improving Data Integrity

• Defining the plan of action — Who, what and how

• Moving forward and monitoring progress

• Achieving accountability


Beth Margerison, Director Regulatory Compliance,

Office of Ethics and Compliance - Government Compliance and Reporting,

Novartis Pharmaceuticals Corporation

Greg Maynard, Solution Director, Life Sciences Compliance,

Health Market Science

#5 Meeting Sunshine Requirements While Protecting HCP Relationships

• Develop mutually beneficial transparency reporting — Company, third party and HCP

• Improve HCP inquiry management and accountability – Portal, manual process

and training and communications for employees and third parties

• Protect HCP Relationships – Increase awareness of your external inquiry

requests and frequency, increase communication with HCPs and measure,

improve and maintain an effective and efficient process for engaging with HCPs


Edmund F. Ford, President, EFF Consulting

Ted Carroll, Practice Director of Data Strategy, CSC

#3 Collecting and Reporting Clinical Spend

• Explore training and communication initiatives that resonate

with those in the clinical function areas

• Discuss how to capture and report spend for HCPs versus HCOs

• Share approaches for working with CROs


Mark Farrar, Associate Director, Navigant Consulting, Inc.

Saul B. Helman, M.D., Managing Director, Navigant Consulting, Inc.

Tracy A. Hegarty, MPH, MPA, Associate Director, Regulatory Compliance,

Novartis Pharmaceuticals Corporation

Nikki Reeves, Partner, FDA and Life Sciences Practice, King & Spalding LLP

#6 Global Transparency Operational Preparedness

• Learn policies and processes to put in place to work with ex-U.S. affiliates who

want to engage U.S. HCPs to ensure spend capture

• Examine approaches to develop a customer master and aggregate spend

technology solution for doctors around the world

• Discuss ways to manage cross-border spend capture and reporting

• Explore how to leverage lessons learned through state and federal reporting to

global transparency efforts


Mark Scallon, Partner, Polaris Management Partners

Ben Carmel, Manager, Polaris Management Partners

Jennifer McGee, Senior Compliance Counsel, Otsuka America Pharmaceutical, Inc.

4 : 0 0 • C l o s e o f C o n f e r e n c e



D i s t i n g u i s h e d S p o n s o r s

A b o u t o u r C o m p l i a n c e C o n s u l t i n g L e a d e r s C i r c l e

2012 Silver Sponsor

Huron Life Sciences understands pharmaceutical, biotech and medical device companies in today’s environment. We combine

subject matter expertise with years of business, scientific and regulatory experience to provide customized solutions, built on

innovative strategies and best practices, to help clients mitigate compliance risk and maximize operational and financial performance.

Transparency and Disclosure • CIA/IRO Support • Compliance Monitoring and Auditing • Fair Market Value Determination • Government

Price Reporting • Litigation and Investigation Support. For more information, contact Paul Silver, Practice Leader, 678-672-6160,

2012 Affiliate Sponsors

PwC’s Pharmaceutical and Life Sciences Industry Group and is dedicated to delivering effective solutions

to the complex strategic, operational and financial challenges facing pharmaceutical, biotechnology and medical device companies. We provide industry-focused

assurance, tax and advisory services to build public trust and enhance value for our clients and their stakeholders. More than 163,000 people in 151 countries

across our network share their thinking, experience and solutions to develop fresh perspectives and practical advice.

Navigant is a specialized, global expert services firm dedicated to assisting clients in creating and protecting value in the face of critical business risks and

opportunities. Our professionals combine litigation and investigative experience with industry knowledge to assist pharmaceutical, medical device and diagnostic

clients with compliance and risk mitigation services; dispute resolution and litigation support; fraud and other special investigations; antitrust matters; class action

services; breach of contract analysis; and data analysis and information systems consulting.

CFS is a specialty provider focused on the business and financial management activities for clinical trials. The company offers a unique blend of contract,

regulatory, and cutting edge investigator grant payment management services, which operate in unison to accelerate cycle times, manage compliance

and risk, and stimulate investigator relationships. With our focused expertise, innovative processes, and integrated technology we are able to provide

high quality, cost effective service solutions that address critical study startup and financial issues affecting the clinical trials process.

Founded in 2005, Bull’s Eye Innovations (BEI) has consistently provided innovative solutions to the unique challenges of the healthcare industry. BEI’s flagship

product is The Aggregate Spend RoadMap®, a proprietary template-based advisory methodology designed to provide pharmaceutical, biotech and medical device

clients with a predictable and efficient approach to addressing spend disclosure and transparency requirements. The methodology remains unparalleled, as it allows

clients to choose a traditional full service model or customized training workshops and remote advisory support. Visit

T o R e g i s t e r C a l l T o l l F r e e 8 0 0 - 8 1 7 - 8 6 0 1 ( 3 3 9 - 2 9 8 - 2 1 0 0

About Our Educational Sponsor:

KPMG has assisted manufacturers with various

aspects of state-specific and aggregate spend

tracking, HCP contracting, and other related

matters. We deliver strategic approaches in an

efficient manner with a multidisciplinary team

that includes former industry executives, CPAs,

MDs, JDs, CFEs and former prosecutors.

Our Pharmaceutical professionals use

their experience, industry focus, and, most

importantly, insight to assist Pharmaceutical

and Healthcare companies with identifying and

managing compliance risks.


Who Should Attend:

You will benefit from attending this event

if you are an executive or senior-level director from

the pharmaceutical, biotech, medical device or medical

supply company with responsibilities or involvement in

the following areas:

Power. Performance. Passion.

Aggregate Spend Reporting

• Ethics and Compliance

• Regulatory Affairs

• Business Analytics

• Commercial Operations

• Corporate Communications

• Transparency

• Legal

• Finance

• Audit

A G r e a t P l a c e t o M e e t Yo u r M a r k e t !

Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while

demonstrating thought leadership and sharing expertise. For more information on how to position your company

as a sponsor or exhibitor, contact Jamie McHugh at 339-298-2106 or email

This conference also benefits law firms, consultants and

technology service providers who supply the industry

with assistance in meeting Sunshine and transparency

requirements through legal interpretations, strategic

management initiatives, data capture and analytics.

o u t s i d e t h e U . S . ) o r v i s i t w w w . c b i n e t . c o m / a g g s p e n d



to Register





339-298-2100 outside the U.S.



w w w . c b i n e t . c o m / a g g s p e n d

CBI’s 6th Annual Forum on Sunshine and Aggregate Spend

Registration Fee:

Standard Advantage Pricing

Conference and Workshop $2595 $2295

Conference $2295 $1995

Register by June 15, 2012 and SAVE $300. Fee includes continental breakfast, lunch,

wine and cheese reception, refreshments and conference documentation. Please make checks

(in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.)

PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate.

Team discount:

Attend this conference for FREE if you bring 3 registered colleagues with you. Colleagues from within your

organization and colleagues external to your organization qualify as team members. All registrations must be

made at the same time to qualify.

satisfaction guaranteed:


CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference,

a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-8601

for further information. Advanced preparation for CBI conferences is not required.

substitution and cancellation:

Your registration may be transferred to a member of your organization up to 24 hours in advance of the

conference. Cancellations received in writing on or before 14 days prior to the start date of the event

will be refunded, less a $295 administrative charge. No refunds will be made after this date; however,

the registration fee less the $295 administrative charge can be credited to another CBI conference if

you register within 30 days from the date of this conference to an alternative CBI conference scheduled

within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the

conference registration fee only. CBI reserves the right to alter this program without prior notice.

Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation,

every effort to find a suitable replacement will be made without notice. The opinions of the conference

faculty do not necessarily reflect those of the companies they represent or CBI.

The Next Best Thing to Being There:


600 Unicorn Park Drive

Woburn, MA 01801

Order the Online Compendium if you would like to capture what you’ve missed at the conference. It couldn’t

be easier. The link to the online compendium is available for only $298 and includes the conference agenda,

presentations and speakers biographies. Next day access is delivered through email on past conferences or

two weeks post-conference on future events. Call 800-817-8601 to order a compendium now.


CALL Juliet Nelson 339-298-2140



Conference options:

August 14, 2012: (choose one) Workshop A Workshop B

August 16, 2012: (choose one) Track A Track B

Working Group Discussions (choose one) —

Topic 1 Topic 2 Topic 3

Topic 4 Topic 5 Topic 6


Renaissance Washington DC Downtown

999 Ninth Street NW • Washington, DC 20001

Phone reservations: (800) 468-3571 • Hotel direct line: (202) 898-9000


Photos by: Photolink / Getty Images


To receive CBI’s special discounted hotel rate online or by phone, please go to:

• Online:

• Phone reservations: 800-468-3571 and mention CBI’s Aggregate Spend.

Cut-off date is July 27, 2012. Reservations made after the cut-off date or after group room block has

been filled (whichever comes first) will be accepted on a space and rate availability basis. Rooms are

limited so please book early. All travel arrangements are subject to availability.

August 14 -16, 2012 • Renaissance Downtow n • Wa s hington, DC


Case study examples from

companies large and small,

representing pharma and device

June 2012

Deadline Set by

Senators Grassley and Kohl

for Final Regulations to Be Issued





January 2013

CMS Requires

Data Collection

to Begin

Stay Ahead of the Curve to Ensure Transparency Readiness

August 2012


The interactive format encourages

peer-to-peer discussions on the

practical solutions related to

aggregate spend execution

Sunshine and Aggregate Spend


6 th Annual


The Longest Running and Best-Attended Meeting on


Credits Available!

Pending Approval


CMS requires data collection

starting in January — This meeting

addresses what you need to know


Top Three Reasons to Attend:

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